Safety overview with modakafusp alfa
| TEAE . | n (%) for indicated dose of modakafusp alfa . | Total (N = 146) . | |
|---|---|---|---|
| 120 mg q4w (n = 71) . | 240 mg q4w (n = 75) . | ||
| Any TEAE | 70 (98.6) | 75 (100) | 145 (99.3) |
| Drug-related TEAEs | 67 (94.4) | 72 (96.0) | 139 (95.2) |
| Grade ≥3 TEAEs | 64 (90.1) | 72 (96.0) | 136 (93.2) |
| Drug-related grade ≥3 | 61 (85.9) | 64 (85.3) | 125 (85.6) |
| Serious TEAEs | 28 (39.4) | 33 (44.0) | 61 (41.8) |
| Drug-related serious TEAEs | 12 (16.9) | 13 (17.3) | 25 (17.1) |
| TEAEs leading to drug discontinuation | 7 (9.9) | 10 (13.3) | 17 (11.6) |
| On-study deaths | 4 (5.6) | 5 (6.7) | 9 (6.2) |
| Most common TEAEs∗ | |||
| Thrombocytopenia | 53 (74.6) | 63 (84.0) | 116 (79.5) |
| Neutropenia | 48 (67.6) | 55 (73.3) | 103 (70.5) |
| Anemia | 31 (43.7) | 33 (44.0) | 64 (43.8) |
| Fatigue | 21 (29.6) | 28 (37.3) | 49 (33.6) |
| Leukopenia | 18 (25.4) | 25 (33.3) | 43 (29.5) |
| Cough | 12 (16.9) | 21 (28.0) | 33 (22.6) |
| IRR | 18 (25.4) | 12 (16.0) | 30 (20.5) |
| Nausea | 9 (12.7) | 21 (28.0) | 30 (20.5) |
| Diarrhea | 14 (19.7) | 13 (17.3) | 27 (18.5) |
| Dyspnea | 7 (9.9) | 16 (21.3) | 23 (15.8) |
| Pneumonia | 10 (14.1) | 13 (17.3) | 23 (15.8) |
| Decreased appetite | 8 (11.3) | 14 (18.7) | 22 (15.1) |
| Headache | 13 (18.3) | 9 (12.0) | 22 (15.1) |
| Pyrexia | 6 (8.5) | 14 (18.7) | 20 (13.7) |
| AST increased | 7 (9.9) | 11 (14.7) | 18 (12.3) |
| Upper respiratory tract infection | 6 (8.5) | 12 (16.0) | 18 (12.3) |
| ALT increased | 6 (8.5) | 11 (14.7) | 17 (11.6) |
| Asthenia | 7 (9.9) | 10 (13.3) | 17 (11.6) |
| Hypokalemia | 6 (8.5) | 9 (12.0) | 15 (10.3) |
| TEAE . | n (%) for indicated dose of modakafusp alfa . | Total (N = 146) . | |
|---|---|---|---|
| 120 mg q4w (n = 71) . | 240 mg q4w (n = 75) . | ||
| Any TEAE | 70 (98.6) | 75 (100) | 145 (99.3) |
| Drug-related TEAEs | 67 (94.4) | 72 (96.0) | 139 (95.2) |
| Grade ≥3 TEAEs | 64 (90.1) | 72 (96.0) | 136 (93.2) |
| Drug-related grade ≥3 | 61 (85.9) | 64 (85.3) | 125 (85.6) |
| Serious TEAEs | 28 (39.4) | 33 (44.0) | 61 (41.8) |
| Drug-related serious TEAEs | 12 (16.9) | 13 (17.3) | 25 (17.1) |
| TEAEs leading to drug discontinuation | 7 (9.9) | 10 (13.3) | 17 (11.6) |
| On-study deaths | 4 (5.6) | 5 (6.7) | 9 (6.2) |
| Most common TEAEs∗ | |||
| Thrombocytopenia | 53 (74.6) | 63 (84.0) | 116 (79.5) |
| Neutropenia | 48 (67.6) | 55 (73.3) | 103 (70.5) |
| Anemia | 31 (43.7) | 33 (44.0) | 64 (43.8) |
| Fatigue | 21 (29.6) | 28 (37.3) | 49 (33.6) |
| Leukopenia | 18 (25.4) | 25 (33.3) | 43 (29.5) |
| Cough | 12 (16.9) | 21 (28.0) | 33 (22.6) |
| IRR | 18 (25.4) | 12 (16.0) | 30 (20.5) |
| Nausea | 9 (12.7) | 21 (28.0) | 30 (20.5) |
| Diarrhea | 14 (19.7) | 13 (17.3) | 27 (18.5) |
| Dyspnea | 7 (9.9) | 16 (21.3) | 23 (15.8) |
| Pneumonia | 10 (14.1) | 13 (17.3) | 23 (15.8) |
| Decreased appetite | 8 (11.3) | 14 (18.7) | 22 (15.1) |
| Headache | 13 (18.3) | 9 (12.0) | 22 (15.1) |
| Pyrexia | 6 (8.5) | 14 (18.7) | 20 (13.7) |
| AST increased | 7 (9.9) | 11 (14.7) | 18 (12.3) |
| Upper respiratory tract infection | 6 (8.5) | 12 (16.0) | 18 (12.3) |
| ALT increased | 6 (8.5) | 11 (14.7) | 17 (11.6) |
| Asthenia | 7 (9.9) | 10 (13.3) | 17 (11.6) |
| Hypokalemia | 6 (8.5) | 9 (12.0) | 15 (10.3) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase.
Experienced by at least 10% of patients overall.